CoreValve Injunction a Win for Edwards in Next Round of TAVI Patent Battle

Late last week Edwards Lifesciences announced that the U.S. District Court for the District of Delaware had granted a preliminary injunction, limiting the sale of Medtronic’s CoreValve system in the United States. The court ordered the injunction to go into effect in seven business days.

Background

Last summer we covered the story of Edwards and Medtronic battling it out in Europe over the Spenser patent. The result was an injunction that, for a short time, excluded CoreValve from the German market, before an appeal to the European Patent office overturned that decision, declaring the patent invalid and effectively ending that line of argument for Edwards.

Fast forward to last week’s hearing, which related to another piece of Edwards IP, the so-called Andersen Patent. This one goes back a long way too, originally having been issued in 1995. A federal jury in 2010 found that CoreValve willfully infringed the Andersen Patent it, a decision that was upheld in 2012. Furthermore Medtronic’s request for a subsequent appeal to the U.S. supreme court was also rejected late last year.

So what’s happened now is that the finding of infringement has turned into an injunction, effectively meaning that from this Friday (April 18th) Medtronic will be unable to sell its CoreValve in the United States.

At the conclusion of the hearing, Chief Judge Gregory Sleet ordered Edwards and Medtronic to confer on what instances the CoreValve device could continue to be used in the treatment of U.S. patients at centers currently trained on CoreValve.

It’s pretty clear that Edwards will continue to hold a firm course in defending its SAPIEN product family, pointing to a large body of evidence demonstrating the safety and performance of the valves. Less clear is what course of action Medtronic now has in the matter. The company has reportedly applied for a “stay” of the injunction, without which it could be effectively out of the U.S. market for the next couple of years Edwards having filed a petition with the U.S.P.T.O to extend the Andersen patent until 2016. That would arguably give Edwards a head start akin to half a marathon.